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NOT YET RECRUITING
NCT07776652
NA

THE EFFECT OF POSTURAL BİOFEEDBACK ON DİSEASE ACTİVİTY AND PAİN İN INDİVİDUALS WİTH AXİAL SPONDYLOARTHRİTİS

Sponsor: Istanbul University - Cerrahpasa

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether adding a wearable postural biofeedback device to a standard exercise program affects disease activity, pain, and functional parameters in individuals with axial spondyloarthritis. The main questions it aims to answer are: Does adding postural biofeedback to a standard exercise program improve disease activity? Does adding postural biofeedback to a standard exercise program reduce pain? Does adding postural biofeedback improve functional parameters, including spinal mobility, quality of life, posture, and functional exercise capacity? Researchers will compare a standard exercise program with the same exercise program combined with a wearable postural biofeedback device to determine whether the addition of postural biofeedback provides greater benefits. Participants will: Participate in a physiotherapist-supervised standard exercise program twice a week for 8 weeks Use the wearable postural biofeedback device three days per week for at least 3 hours per day during prolonged static posture activities if assigned to the intervention group Complete assessments before and after the 8-week intervention, including measures of disease activity, pain, physical function, spinal mobility, quality of life, posture, and functional exercise capacity

Official title: THE EFFECT OF POSTURAL BİOFEEDBACK COMBİNED WİTH STANDARD EXERCİSE ON DİSEASE ACTİVİTY, PAİN, AND FUNCTİONAL PARAMETERS İN INDİVİDUALS WİTH AXİAL SPONDYLOARTHRİTİS: A RANDOMİZED CONTROLLED TRİAL

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2026-10-01

Completion Date

2027-06-30

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Standard Exercise Program

Participants in both study groups will receive a standard exercise program for 8 weeks, with two physiotherapist-supervised sessions per week and approximately 45 minutes per session. The program will include warm-up, spinal mobility exercises, stretching exercises, postural exercises, trunk stabilization exercises, lower extremity strengthening exercises, breathing exercises, and cool-down. Exercises will be performed at moderate intensity according to the participant's clinical condition and exercise tolerance. Set number, repetitions, and resistance will be progressively increased by the physiotherapist according to individual performance.

BEHAVIORAL

Wearable Postural Biofeedback

Participants in the intervention group will additionally use a wearable postural biofeedback device (Kodgem Straight™, Türkiye) for 8 weeks. The device uses inertial sensors to monitor the position of the upper thoracic region in real time and provides vibrotactile feedback when a predefined postural threshold is exceeded. The device will be individually calibrated before use. Participants will be instructed to use the device three days per week for at least 3 hours per day during activities requiring prolonged static posture, such as desk work, computer use, meal preparation, or ironing. Device adherence will be monitored and recorded by the researcher.

Locations (1)

Istanbul University-Cerrahpasa, Faculty of Health Sciences

Istanbul, Istanbul, Turkey (Türkiye)